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OpenTrials
Completed

NCT Number: NCT00548678

Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Comprehensive Phase One

Miramar, Florida, 33025, United States

About this study

The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects.
  • Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.

Exclusion criteria

  • Bleeding abnormalities or cardiovascular events.
  • Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Treatment and study plan

Intravenous diclofenac sodium (DIC075V)

Drug

intravenous diclofenac sodium

Ketorolac

Drug

intravenous ketorolac

oral diclofenac (Cataflam)

Drug

oral diclofenac (Cataflam)

Aspirin

Drug

oral aspirin

Primary outcomes

  1. Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.

    Time frame: 6 hours

Secondary outcomes

  1. The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Javelin Pharmaceuticals

Industry

Registry information

Official study title

Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 24, 2007
Registry last updated
Jul 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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